Analytical Instrument

Practical Approaches for

Qualification USP General Chapter <1058>

Compliance in the QC Laboratory

SPEAKERS:

Jörg Kastenschmidt
Merck, Germany

Philip Lienbacher
Shire, Austria

Image: BÜCHI
Participate in 4 Workshops!
Roland Miksche
Austria

21 – 23 February 2018, Copenhagen, Denmark

LEARNING OBJECTIVES:

„„ Regulatory Aspects of Analytical Instrument Qualification

„„ USP General Chapter <1058> - Analytical Instrument Qualification
„„ Risk Assessment in Analytical Laboratories
„„ Calibration Management
„„ Balances and Weighing Processes
„„ Practical Examples of Analytical Instrument Qualification
and Calibration:
-- Spectroscopic Instruments and Detectors (UV/VIS, IR, NIR, NMR, etc.)
-- pH Measuring Instruments
-- HPLC / GC
-- RAMAN / NIR / FT-IR
-- Thermometers and Hygrometers
„„ Computer Validation in Analytical Laboratories
„„ Validation of Excel® Spreadsheets
„„ Data Integrity Challenges in Calibration and Qualification

This education course is recognised for the ECA GMP Certification Programme „Certified Quality Control Manager“.
Please find details at www.gmp-certification.eu
Analytical Instrument Qualification
21 – 23 February 2018, Copenhagen, Denmark
Learning Goals
Calibration and qualification of equipment are key require-
ments in GMP guidelines (EU GMP Guide, Annex 15 to EU
GMP Guide, and FDA’s Code of Federal Regulations, 21 CFR
Part 211). These requirements also apply to instruments and
systems in analytical laboratories of the pharmaceutical in-
dustry. Besides calibration and qualification, the validation
of computerised systems is another key issue. The software
components associated with the instruments and systems
must be shown to be fit for their intended purpose. Com-
puter validation requirements and guidances for the phar-
maceutical industry are laid down, amongst others, by the
EU (Annex 11 to EU GMP Guide, the PIC/S (Good Practices
for Computerised Systems in Regulated “GXP” Environ-
ments”), GAMP® (Good Automated Manufacturing Prac-
tice), and FDA’s Part 11.
The United States Pharmacopoeia (USP) has adopted the
General Chapter <1058>, Analytical Instrument Qualifica-
tion, in 2008. This General Chapter <1058> has just been
updated in 2017.
The objective of this course is to provide the participants
with an overview of the regulatory requirements on the
qualification of analytical equipment and the software vali-
dation of computerised systems and to give practical advice
on successful approaches to calibration, qualification, vali-
dation, and routine monitoring of instrumentation and sys-
tems. Key requirements of the important USP General
Chapter <1058> will be presented and discussed.
The course will cover the following instruments and systems
amongst others:
„„ UV/VIS Spectrophotometers,, Disintegration and Dis-
solution)
„„ Balances and Masses
„„ pH
„„ RAMAN / NIR / FT-IR
„„ HPLC and GC
„„ Chromatographic Data Systems
„„ Excel® - Spreadsheets
Interactive workshops will allow the participants to discuss
key areas of interest and to exchange practical experiences.
Target Group
This GMP Education Course will be of practical value to
scientists and engineers in analytical laboratories and con-
tract laboratories in an FDA-/GMP-regulated environment
who are responsible for the calibration and qualification
of their laboratory equipment and for the validation of the
computerised systems used in their laboratories.
Programme
Regulatory Aspects of Analytical Instrument
Qualification
„„ Overview about legislations including
-- Europe: EU GMP Guide - Annex 15
-- US: CFR, USP
-- National: German ZLG quality manual
„„ Other relevant documents (Interpretation documents)
and authority expectations
„„ Overview about Qualification steps
„„ Equipment life cycle
USP General Chapter <1058> - Analytical Instrument
Qualification
„„ Key recommendations of this USP General Chapter
„„ Qualification steps: which activities should be
performed in each phase?
„„ Roles and responsibilities for the user, Quality
Assurance and for the manufacturer/vendor
„„ Software validation, Change Control &
Documentation
„„ Instrument categories
General Aspects of Calibration
„„ Overview: regulatory aspects / requirements
„„ Definitions / terminology
„„ Concepts and documentation
„„ Handling OOC (Out of Calibration)
WORKSHOP I
Topic: Apparatus & Instruments List Case Study / Risk
Categorisation According to USP <1058>
MODERATOR: Joerg Kastenschmidt
Risk Assessment in Analytical Laboratories
„„ Scaring examples
„„ Advantages of minimizing risk
„„ Definition and regulation (EU GMP Part 3 - Quality Risk
Management, etc.).
„„ Approach, applicability, documentation, approvals
„„ FMEA (Failure Mode and Effect Analysis)
„„ HACCP (Hazard Analysis and Critical Control Points)
„„ ISHIKAWA DIAGRAM (Fishbone)
„„ FTA (Fault Tree Analysis)
„„ Risk assessment of changes
WORKSHOP II
Topic: Qualification / Risk Analysis of pH Measuring
Instruments
MODERATOR: Roland Miksche
Calibration Management Volumetric Apparatus (Pipets, Dispensers, etc.)
„„ Parts of a calibration management system „„ Selection of suitable apparatuses
-- Procedure(s) „„ Qualification / calibration
-- Documentation „„ Volumetric laboratory glassware
-- Calibration standards
-- Calibration management software Assurance of Controlled Temperature and Humidity
„„ Calibration interval adjustment „„ Thermometers and thermometry
„„ OOC/OOT evaluation „„ Hygrometers and hygrometry
„„ What can go wrong and how to avoid it „„ Qualification approaches to
-- Refrigerators and freezers
Data Integrity Challenges in Calibration and -- Climatic storage rooms and incubators
Qualification -- Ovens & muffle furnaces
„„ Relevant Guidelines -- Water baths
„„ Documentation- & Data-management-Systems in the
Pharma/Device industry General Aspects of Computer Validation in Analytical
„„ Achieving data integrity: Creating a culture of quality Laboratories
around document- and data management „„ PIC/S Guidance Good Practices for Computerised
„„ What can go wrong and how to avoid it! Systems in Regulated “GXP” Environments
„„ New EU GMP Annex 11 Computerised Systems
Qualification of Specific Instruments and Systems „„ Requirements of 21 CFR Part 11
„„ Requirements according to USP „„ Life cycle concept
„„ Traceability of standards „„ Integration of equipment qualification and computer
„„ Practical approaches to qualification and calibration of validation
-- UV-Visible „„ Retrospective validation
-- Dissolution
-- Disintegration HPLC / Chromatography Data Systems – Integrated
-- Osmometer Qualification and Validation
-- Particulate Matter „„ Master Validation Plan (MVP)
-- Turbidity „„ Assessments (Risk to Quality, 21 CFR Part 11)
-- Dishwasher „„ User Requirement Specification (URS)
„„ Function- and Design Specification (FS/DS)
Qualification of GC Instruments „„ Risk Analysis (RA)
„„ Warning Letters (483) and Findings „„ Validation Protocol (VP)
„„ Technical Overview, Applications „„ Test Cases (Deviations, Incidents, Changes)
„„ From Vendor to Decommissioning: AIQ-Lifecycle „„ Final Report (FR)
„„ System Suitability Test „„ Standard Operation Procedures (SOP)
„„ Periodic Review (Checklist) „„ Forms (User Access, Monitoring, Updates...)
„„ Service Contracts, Helpdesk, Logbook
Balances and Weighing Processes
„„ Weighing basics Validation of Excel® Spreadsheets
„„ Environmental influences on weighing „„ Areas of Usage
„„ Practical aspect on weighing „„ Known Errors and Findings
„„ Requirements acc. to USP <41> and <1251> „„ Categorisation according GAMP
„„ Qualification and calibration of balances „„ Lifecycle Phases and Documentation:
„„ Weights (OIML R111-1) -- Requirements Phase
-- Definition, Build Phase
-- Testing Phase
WORKSHOP III -- Release
Topic: Balances -- Changes, Decommissioning
MODERATOR: Joerg Kastenschmidt „„ Literature (Regulations, Guidances)

Qualification of RAMAN / NIR / FT-IR WORKSHOP IV

„„ Quick overview RAMAN / NIR / FT-IR & benefits
„„ Qualification: What are the specifics?
„„ Potential difficulties
Topic: Validation of Excel Spreadsheets
(Categorisation, responsibilities, required docu-
ments, contents of documents, testing, versioning,
data handling)
MODERATOR: Roland Miksche
Speakers

JOERG KASTENSCHMIDT
Merck, Darmstadt, Germany
Jörg Kastenschmidt is an engineer of chemi-
cal and bio-technology. He started his
career in 2001 as project engineer at the
PHAST GmbH in Homburg/Saar. After work-
ing in the GMP processes unit within the pharmaceutical
analytical development at Merck for 10 years, he joined
the development QA in 2016, where amongst other
things he is responsible for qualification of analytical
instruments, production equipment / facilities and
validation of IT-systems.

PHILIP LIENBACHER,
Shire, Vienna, Austria
Philip Lienbacher started his career within
Shire (previously Baxter/Baxalta) in 2008 in
Vienna. Since then he held a variety of roles
inside quality. In 2014, he accepted the posi-
tion of Manager Global Material Lifecycle Management
Systems and is responsible for a team of process experts
and project managers. His responsibility includes the
global ownership for Receiving & Inspection as well as
the general testing- and method deployment-strategy in
the company.

ROLAND MIKSCHE
Vienna, Austria
After more than 15 years driving CSV, data
integrity and all global IT-projects within the
Quality Assurance Department of Shire, he
implemented EBM, an electronic batch
management system, at Shire and afterwards, as Senior
Consultant of HGP Pharma Consulting, at a customer in
Germany. He made his final exam in biochemistry in Vi-
enna, Austria, worked as analyst in accredited laborato-
ries and as a sales and service expert for scientific equip-
ment.

Social Event

In the evening of the first course day all participants and

speakers are invited to a guided sight-seeing tour of the
city of Copenhagen, followed by a dinner, where the
topics of the course can be further discussed in a relaxed
atmosphere.
ECA Education Course
Reduced Sampling/Reduced Testing
19-20 February 2018, Copenhagen, Denmark

Directly before this ECA Education Course Analytical

Instrument Qualification on 19-20 February 2018 there
will be the ECA Education Course Reduced Sampling/
Reduced Testing with these topics:

„„ Regulatory Requirements for Sampling Procedures

„„ Design and Qualification of Sampling Areas for In-
coming Goods Products
„„ Supplier Qualification: an important Prerequisite for
Reduced Sampling and Reduced Testing
„„ How to Deal with Divergent Compendial Method
Requirements (EP, USP, JP)
„„ Case Study I: How to Define Inspection Procedures
for
Packaging Materials (Primary and Secondary) in the
Incoming Goods Control
„„ Case Study II: How to Define and Optimise Sampling
and Testing Procedures for APIs and Excipients in the
Incoming Goods Control
„„ Sampling and Documentation to make the Supplier
liable for Defect Products

Further details will be discussed in a parallel session

with 3 workshops.

Further information about this course can be received

at www.gmp-compliance.org.

Participants who register simultaneously for both cours-

es will receive a 350 € discount (not valid for EU GMP
Inspectorates).
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pling / Reduced Testing from 19-20 February 2018 at the

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WA/17082017